MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE LIGATING DEVICE

Model Number HX-400U-30

Device Problem Difficult to Remove (1528)

Patient Problems Hemorrhage/Bleeding (1888); Insufficient Information (4580)

Event Date 05/22/2023

Event Type  Injury  

Event Description

An olympus representative reported to olympus on behalf of the customer that the loops no longer come off when using the ligator during an endoscopic mucosal resection.The coil sheath was protruding from the patient's mouth.The doctor inserted a high frequency snare into the scope and was able to release it by cutting the snare under the loop.After that, he stopped the bleeding with a clip.Due to this malfunction, the procedure was delayed for about 30 minutes.Additional information was later received clarifying that the indwelling snare became stuck, and the coil sheath was cut to remove the scope, resulting to the coil sheath coming out of the patient's mouth.There were no reports of any adverse effects from the reported incident with the coil sheath.The onset of occurrence of the bleed, its severity, and any other additional interventions done including the patient's latest health status were unknown.

Manufacturer Narrative

The suspect device has been returned to olympus.The sheath was severed at approximately 2,265 millimeters from the distal end of insertion portion.The loop was connected to the device, and the stopper was attached to the loop.However, the stopper was damaged.The condition of the connection between the loop and the hook was inspected by stretching the coil sheath.The rear end of the loop was not properly connected to the hook, and the loop was caught in between the coil sheath and the hook.The subject device was demolished to remove the loop from the coil sheath.The rear of the loop was deformed.The distal end of the loop was severed.The hook presented no abnormalities such as deformation or bending.Other abnormalities that could lead to the reported event were not confirmed.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported issue.The instructions for use (ifu) contains the following: do not strike or crush the coil sheath during operation.Doing so can damage the distal end of the coil sheath, which could make it impossible to detach the loop after ligation.In this case, refer to ¿emergency treatment¿ and ¿equipment to be used in an emergency¿ sections.Do not remove the loop from the hook while the coil sheath is not extended from the tube sheath.Otherwise, the loop may be tangled with the hook and become impossible to be removed.In this case, refer to ¿emergency treatment¿ and ¿equipment to be used in an emergency¿ sections.Do not hold the loop with the distal end of the tube sheath while the loop is surrounding the tissue.Otherwise, when the tissue is ligated, the loop may be detached from the hook in the tube sheath and tangled with the hook.That may make the loop impossible to be removed.In this case, refer to ¿emergency treatment¿ and ¿equipment to be used in an emergency¿ sections.Never use excessive force to operate the instrument.This could damage the instrument.The root cause for the reported event could not be confirmed.Based on the investigation result, a likely mechanism causing the reported event might be the following: the loop was surrounding the body tissue, and it was temporarily ligated by pulling the slider.The tube sheath was pushed out, and the distal end of the coil sheath went into the tube sheath.An attempt was made to detach the loop in state of above description.Therefore, the loop detached from the hook in the tube.While the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.The hook was pulled.This caused the hook and the loop to retract into the coil sheath together.As a result, the loop and the hook got stuck inside the coil and could not move.Since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.Based on the provided information, it can be inferred that the loop was severed by a snare, and that the sheath was severed by a tool, for emergency measures.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: SINGLE USE LIGATING DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17168069
• MDR Text Key: 317809368
• Report Number: 9614641-2023-00874
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 1XK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention